FDA.reportPublic FDA data

Huestis Centralite Patient Positioning Laser

Primary DI
00850077007255
Brand
Huestis Centralite Patient Positioning Laser
Company
HUESTIS MACHINE CORPORATION
Model
CTL-DLL-2214
Device description
KIT CONTAINS 2 DLL-2 RED CROSS LASERS, 1 DLL-4 RED SAGITTAL LASER
Published
2021-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850077007255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077007255008500770072558500770072550850077007255

GMDN Terms#

Term, Definition table
TermDefinition
Laser patient positioning systemA fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
401-253-5500sales@huestis.com

Regulatory Flags#

DUNS number
001188390
Device count
1
Premarket exempt
true
Kit
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077007293Huestis Medical Flexi-HolderFH303DP-122025-03-05
00850077007286Huestis Medical CollimatorCM-32211-QMI2021-04-02
00850077007279Huestis Medical CollimatorCM-3201-1022021-03-19
00850077007262Huestis Centralite Patient Positioning LaserCTL-DLG-22142021-02-18
00850077007217Huestis Centralite Patient Positioning LaserDLG22021-02-04
00850077007224Huestis Centralite Patient Positioning LaserDLL22021-02-04
00850077007231Huestis Centralite Patient Positioning LaserDLL42021-02-04
00850077007248Huestis Centralite Patient Positioning LaserDLG42021-02-04
00850077007002Huestis Medical CollimatorCM-11002016-07-01
00850077007019Huestis Medical CollimatorCM-3201-0082016-07-18
00850077007026Huestis Medical CollimatorCM-32012-0082016-07-18
00850077007033Huestis Medical CollimatorCM-10032016-07-18
00850077007040Huestis Medical Flexi-HolderFH410-GE2016-07-18
00850077007057Huestis Medical CollimatorCM-3300B-0022016-07-18
00850077007064Huestis Medical CollimatorCM-32001-COV2016-07-18
00850077007071Huestis Medical Flexi-HolderFH3032017-06-19
00850077007088Huestis Medical Flexi-HolderFH303-12016-11-01
00850077007095Huestis Medical Flexi-HolderFH4102016-11-01
00850077007101Huestis Medical Flexi-HolderFH410-12016-11-01
00850077007118Husetis Medical Flexi-HolderFH410-GE2016-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977071931271MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931288MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931295MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931301MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931318MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931325MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931332MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931356MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931363MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931400MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931479MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931486MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931493MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931509MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931516MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931585MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931592MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931608MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931615MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931622MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931639MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931646MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26